DBV Technologies announced the receipt of Written Responses from the FDA on key study design elements for the COMFORT Toddlers and COMFORT Children supplemental safety studies. The company closed Q2 2023 with a cash balance of $174 million.
Received FDA feedback on design elements for Viaskin Peanut safety studies.
COMFORT Toddlers will be a 6-month safety study.
The Company expects to seek final alignment with FDA on the COMFORT protocols prior to commencing the studies.
DBV closed Q2 2023 with a cash balance of $174 million.
This press release contains forward-looking statements and estimates, including statements regarding DBV’s forecast of its cash runway, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies, and the outcome of any litigation.